Self retracting needle apparatus and method for phlebotomy

• US 6,063,040 A
• Filed: 01/16/1998
• Issued: 05/16/2000
• Est. Priority Date: 01/16/1998
• Status: Expired due to Fees

• Current Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Original Assignee: Specialized Health Products, Inc. (Becton, Dickinson & Co)
• Inventors: Thorne, David L., Thorne, Gale H., Barrus, Roy L., Owen, Charles V.
• Primary Examiner(s): O'Connor, Cary
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US09/008,036
• Time in Patent Office: 851 Days
• Field of Search: 600/573, 600/576, 600/578, 604/162, 604/163, 604/171, 604/192
• US Class Current: 600/573
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150656 semi-automatically triggered, i.e. in which the triggering of the protective sleeve requires a deliberate action by the user, e.g. manual release of spring-biased extension means
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/150732 Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube,
• CPC Class Codes: A61B 5/150908 by disconnecting components, e.g. breaking or rupturing of connected parts, e.g. piston and rod
• CPC Class Codes: A61B 5/1545 comprising means for indicating vein or arterial entry
• CPC Class Codes: A61M 2005/3104 Caps for syringes without needle
• CPC Class Codes: A61M 2005/3227 the needle being retracted laterally outside the syringe barrel, e.g. with separate guideway
• CPC Class Codes: A61M 2005/3242 Needle retraction by vacuum
• CPC Class Codes: A61M 5/3232 Semi-automatic needle retraction, i.e. in which triggering of the needle retraction requires a deliberate action by the user, e.g. manual release of spring-biased retraction means

Abstract

A practical, low cost safety device for phlebotomy. Preparation for operation of the device involves elongating an otherwise shortened-for-transport apparatus to extend a medical assembly and needle from a housing for use in a medical procedure. The act of elongating energizes an energy storing component and cocks a releasable latch. The energy storing component is preferably a vacuum drawing plunger and tube combination. When the medical procedure is complete, distortion of a portion of the housing causes powered retraction of the needle. After retraction, the needle is fully contained, permitting the device to be laid aside without fear of an inadvertent needle stick. The housing comprises a proximal barrel and a distal needle containment section. The barrel comprises a sampling tube stopper piercing cannula. The distal section is disposed in-line, but off-axis from the barrel and comprises an enclosed conduit which communicates with the cannula and with a pathway to the medical needle through the medical needle assembly. Construction of the device requires only three injection molded parts, the housing, a needle hub and a needle cover. Further, as the needle is retracted, communication from the conduit is severed and the pathway to the needle is closed to reduce likelihood of blood spatter. The conduit may be used as a blood flash visualization chamber.

Claims

1. A barrel part for use in an extendable and retractable safety medical needle device, said barrel part comprising:

a hollow, cylindrically shaped proximal part comprising a first elongated sidewall, a proximally disposed opening for receiving fluid sampling tubes and a substantially closed distal end comprising a hub having a centrally disposed bore hole wherein a proximally directed sharpened cannula is disposed to provide a communicating pathway into each sampling tube inserted into said proximal part and perforated by said sharpened cannula;

an elongated hollow, tubular portion comprising;

a closed proximal end which forms a wall which is contiguous with said distal closed end; and

a second elongated sidewall having a hollow cylindrical shape for a plunger which when drawn away from said closed proximal end evacuates and essentially produces a vacuum within a volume defined by the closed proximal end, a portion of the second sidewall and the plunger and

a fluid communicating passageway from the plunger to said communicating pathway, said passageway comprising a fluid flow path which is separate and independent from the volume.

2. A barrel part according to claim 1 wherein said second sidewall comprises an internal surface having a catch for a latching part disposed therein.

3. A barrel part according to claim 1 wherein said second sidewall comprises an elongated channel which forms a part of said passageway.

4. A barrel part according to claim 1 wherein said distal portion comprises a tab which restricts removal of the plunger from the tubular portion in which the plunger is disposed.

5. An extendable and retractable safety phlebotomy device comprising:

a housing comprising a proximal hollow, elongated cylindrical portion and a distal hollow, elongated tubular portion;

said proximal portion comprising an open proximal end for receiving fluid sampling tubes and a distal end closed about a needle hub;

a cannula, having a proximally directed sharpened tip, securely affixed in said needle hub and providing a fluid pathway therethrough;

said distal portion comprising a closed proximal end in the form of a wall common with a portion of said distal end, an elongated sidewall defining an interior tubular surface and a distally disposed opening;

a displaceable needle assembly comprising a hub for a medical needle, a hollow medical needle, an energy storing element and a plunger comprising a slidable part having at least two seals defining a blood flow path therebetween and being disposed about said hub and aligned transverse to the interior tubular surface, the needle assembly being disposed within the distal portion prior to use, partially advanced through said distal opening to extend the medical needle for use in a medical procedure and retracted by force generated by conversion of stored energy, created by displacing at least one of the seal parts away from the proximal closed end along the interior tubular surface and stored in the energy storing element, to safely secure the medical needle inside the distal portion after use;

the hub further comprising a releasible latch and the distal portion comprising a catch whereby the needle assembly is releasibly affixed when displaced for the procedure;

said sidewall comprising a closed conduit having an opening at a proximal end which communicates with said fluid pathway and having an opening at a predetermined distal site through said sidewall;

said hub having a fluid communicating recess which delivers fluid from a proximal end of said medical needle into the hollow of said distal portion; and

said at least two seal parts being disposed about said slot and also disposed to provide a sealed pathway from said recess to said site when the needle assembly is displaced for use in the medical procedure.

6. An extendable and retractable safety Phlebotomy device according to claim 5 wherein said at least two seal parts and said distal portion, in combination, form the energy storing element by drawing a vacuum as the needle is displaced distally.

7. An extendable and retractable safety Phlebotomy device according to claim 5 wherein said energy storing element is an elastic member.

8. An extendable and retractable safety Phlebotomy device according to claim 5 wherein said energy storing element is a spring.

9. An extendable and retractable safety phlebotomy device according to claim 5 further comprising a removable label which closes and seals the open proximal end and provides evidence of tampering when removed.

10. An extendable and retractable safety phlebotomy device according to claim 5 further comprising a cap which provides a sterile barrier and denies access to the medical needle until removed.

11. An extendable and retractable safety phlebotomy device according to claim 5 wherein the hub comprises a catch and the device further comprises a cap comprising a releasable fastener which hooks to said hub catch to draw the needle assembly outward from the distal portion as the cap is removed from the device.

12. An extendable and retractable safety phlebotomy device according to claim 5 wherein said interior surface comprises rails and the cap comprises grooves which are complementary with the rails to assure linear extension of said needle as the fastener is pulled from the distal portion,.

13. An extendable and retractable safety phlebotomy device according to claim 5 wherein said seal parts communicate with said side wall to provide closure at the proximal end of said medical needle when said sealed pathway is disjoined as the hub is retracted.

14. An extendable and retractable safety phlebotomy device comprising:

a housing comprising a proximal hollow, elongated cylindrical portion and a distal hollow, elongated tubular portion;

said proximal portion comprising an open proximal end for receiving fluid sampling tubes and a distal end closed about a needle hub;

a cannula, having a proximally directed sharpened tip, securely affixed in said needle hub and providing a fluid pathway therethrough;

said distal portion comprising a closed proximal end in the form of a wall common with a portion of said distal end, an elongated sidewall defining an interior tubular surface and a distally disposed opening;

a displaceable needle assembly comprising a hub for a medical needle, a hollow medical needle, and a plunger comprising at least two slidable seal parts disposed about said hub and aligned transverse to the interior tubular surface, the needle assembly being disposed within the distal portion prior to use, partially advanced through said distal opening to extend the medical needle for use in a medical procedure and retracted by force of vacuum, created by displacing at least one of the seal parts away from the proximal closed end along the interior tubular surface, to safely secure the medical needle inside the distal portion after use;

the hub further comprising a releasible latch and the distal portion comprising a catch whereby the needle assembly is releasibly affixed when displaced for the procedure;

said sidewall comprising a closed conduit having an opening at a proximal end which communicates with said fluid pathway and having an opening at a predetermined distal site through said sidewall;

said hub having a fluid communicating recess which delivers fluid from a proximal end of said medical needle into the hollow of said distal portion; and

said at least two seal parts being disposed about said slot and also disposed to provide a sealed pathway from said recess to said site when the needle assembly is displaced for use in the medical procedure.

15. An extendable and retractable safety phlebotomy device according to claim 14 further comprising a removable label which closes and seals the open proximal end and provides evidence of tampering when removed.

16. An extendable and retractable safety phlebotomy device according to claim 14 further comprising a cap which provides a sterile barrier and denies access to the medical needle until removed.

17. An extendable and retractable safety phlebotomy device according to claim 14 wherein the hub comprises a catch and the device further comprises a cap comprising a releasible fastener which hooks to said hub catch to draw the needle assembly outward from the distal portion as the cap is removed from the device.

18. An extendable and retractable safety phlebotomy device according to claim 14 wherein said interior surface comprises rails and the cap comprises grooves which are complementary with the rails to assure linear extension of said needle as the fastener is pulled from the distal portion.

19. An extendable and retractable safety phlebotomy device according to claim 14 wherein said seal parts communicate with said side wall to provide closure at the proximal end of said medical needle when said sealed pathway is disjoined as the hub is retracted.

20. A safety phlebotomy device comprising;

a housing comprising a proximally disposed portion, having a hollow cylindrical core which is closed at a distal end except for a needle hub and associated through hole which provides for fluid communication therethrough, and a distally disposed portion having a hollow elongated tubular shape and being closed at a proximal end which is integral with the distal end of the proximally disposed portion;

an extendable and retractable medical needle assembly comprising a hollow medical needle which is at least partially disposed in said distally disposed tubular portion and protected by a releasible cover during transport, extended from said housing during use in a medical procedure and retracted for safety into said housing after use;

said medical needle assembly further comprising a slideable seal assembly which acts as a plunger which draws a vacuum in a space within the distally disposed tubular portion when said assembly is displaced to extend said needle for use, said housing and said medical needle assembly cooperatively providing a fluid path, from said medical needle into said hollow core, which is separate from the space within the distally disposed tubular portion in which the vacuum is drawn.

21. A safety phlebotomy device according to claim 20, wherein said distally disposed tubular portion comprises a catch and said medical needle assembly comprises a corresponding releasible latch whereby said assembly is releasibly latched when said needle is extended.

22. A safety phlebotomy device according to claim 20, wherein said distally disposed tubular portion comprises a sidewall having a channel disposed therein which is a segment of the fluid path.

23. A safety phlebotomy device according to claim 20, wherein said distally disposed tubular portion comprises a latch release which is manually actuated to release the latch from the catch permitting energy stored via said vacuum to retract the needle and needle assembly into the distally disposed tubular portion.

24. A safety phlebotomy device according to claim 23, wherein said latch release comprises a cantilevered button integral to said housing.